Do you want to help bring innovative diagnostic imaging technology to new international markets?

For our client, we are currently seeking an experienced and detail-oriented Regulatory Technical Documentation Specialist for an exciting assignment within the medical device industry. This is a unique opportunity for a professional with Clinical Evaluation Report (CER) experience who wants to play a key role in a large-scale regulatory submission for an advanced diagnostic ultrasound system. You will contribute to the development and completion of clinical documentation supporting market registration in China.

You will join an international and multidisciplinary environment consisting of regulatory specialists, clinical experts, quality professionals, and engineering teams. This role is ideal for someone who thrives in complex documentation projects, has a strong eye for detail, and enjoys working across multiple stakeholders and technical disciplines.

The client is looking for someone who can start as soon as possible, ideally within the next 1-2 weeks. The initial assignment is expected to run 3 months. For the right candidate, there may be opportunities to contribute to additional regulatory projects thereafter, depending on business needs and project demands.

This position can be based in either Oslo or Horten and offers a flexible remote working arrangement.

Applicants must already hold a valid residence and work permit for Norway at the time of application.

Apply today to be considered for this opportunity!

In this role, you will play a key part in the development, review, and quality assurance of Clinical Evaluation Reports for an advanced diagnostic ultrasound platform. You will work closely with regulatory, clinical, and engineering stakeholders to ensure high-quality documentation and compliance with regulatory requirements. The role requires strong analytical skills, excellent collaboration abilities, and the confidence to drive technical discussions and obtain critical information from subject matter experts.
Further responsibilities include:

• Drafting, reviewing, and maintaining the Main CER and associated Sub-CERs for a complex ultrasound platform with multiple probes and software features
• Ensuring consistency between CER documentation, technical requirements, study reports, Instructions for Use (IFUs), and supporting regulatory documentation
• Collaborating with engineering, regulatory, and clinical teams to gather documentation, resolve gaps, and support project milestones and submission timelines

The ideal candidate holds a relevant degree within life sciences, biomedical engineering, clinical engineering, regulatory affairs, or a related discipline. You have experience working with regulatory documentation for medical devices and are comfortable managing a large volume of documentation in a fast-paced environment. You are independent, highly organized, and detail-oriented, with a strong ability to drive progress across multiple stakeholders. You are comfortable engaging subject matter experts, asking precise questions, and following up on incomplete information to ensure accuracy, consistency, and traceability. The role requires resilience, adaptability, and the ability to deliver high-quality work under firm project deadlines.

In addition, you have:

• Proven experience authoring or reviewing Clinical Evaluation Reports (CERs) under EU MDR, MEDDEV, FDA, NMPA, or a comparable regulatory framework, with direct NMPA or CMDE submission experience considered a strong advantage
• Experience evaluating technical and clinical documentation, including equivalence assessments, evidence traceability, and safety and performance evaluations, preferably within diagnostic ultrasound, echocardiography, or other advanced imaging technologies
• Professional proficiency in written and spoken English, with working knowledge of Chinese considered an advantage for navigating and cross-checking terminology in supporting documentation

In return, you will have the opportunity to contribute to a highly visible regulatory project within a global medical technology environment. You will join a collaborative and experienced international team and work with advanced products that support modern diagnostic healthcare worldwide.
Furthermore, you will receive:
A key role in a strategically important international project with a direct impact on a major regulatory submission
The flexibility to work remotely while collaborating closely with experienced specialists across engineering, regulatory affairs, clinical affairs, and quality functions
The opportunity to build expertise within a highly specialized and in-demand regulatory field, with potential opportunities to contribute to future projects for the right candidate

Interested? Apply today! Register your application through this job advertisement or contact the responsible Recruitment Advisor at Qualified Professionals for more information. Due to GDPR regulations, we are unable to accept CVs or applications by email. We look forward to hearing from you!

Qualified Professionals connects people and opportunities. Our goal is always to find the right candidate for every unique position. Through deep market insight, both nationally and internationally, combined with a quality-assured recruitment process, we help both clients and candidates succeed. We are more than a recruitment provider. We are a strategic partner for growth within recruitment, staffing, and advisory services.